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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05232864




Registration number
NCT05232864
Ethics application status
Date submitted
31/01/2022
Date registered
10/02/2022

Titles & IDs
Public title
Open-label Extension Study of Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Lupus Nephritis
Scientific title
A Three-year, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Efficacy, Safety and Tolerability in Patients With Active Lupus Nephritis
Secondary ID [1] 0 0
2021-005772-19
Secondary ID [2] 0 0
CAIN457Q12301E1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Secukinumab

Experimental: Secukinumab - Secukinumab 300 mg solution for subcutaneous (s.c.) injection in a 2mL Pre-Filled Syringe (PFS)


Treatment: Drugs: Secukinumab
300 mg solution for subcutaneous (s.c.) injection in a 2mL Pre-Filled Syringe (PFS)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Complete Renal Response (CRR)
Timepoint [1] 0 0
Up to 28 weeks: from enrollment in the extension study (Week 104E1) up to Week 132 or Early termination of the Extension Study. Study day is defined with respect to the core study.

Eligibility
Key inclusion criteria
Key inclusion criteria:

* Subject must have both participated in core study and completed the entire treatment period up to and including Week 104 of the core study CAIN457Q12301.
* Subject must be deemed by the investigator to benefit from secukinumab therapy.
* Signed informed consent must be obtained prior to participation in the study.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
* Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 Weeks). Highly effective methods of contraception are recommended due to the known teratogenic effect of SoC (MPA).

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/08/2023
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novartis Investigative Site - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
CE
Country [2] 0 0
Brazil
State/province [2] 0 0
SP
Country [3] 0 0
Colombia
State/province [3] 0 0
Barranquilla
Country [4] 0 0
Czechia
State/province [4] 0 0
Prague 2
Country [5] 0 0
Czechia
State/province [5] 0 0
Praha
Country [6] 0 0
Guatemala
State/province [6] 0 0
Guatemala City
Country [7] 0 0
Guatemala
State/province [7] 0 0
Guatemala
Country [8] 0 0
Japan
State/province [8] 0 0
Fukuoka
Country [9] 0 0
Japan
State/province [9] 0 0
Miyagi
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seoul
Country [11] 0 0
Philippines
State/province [11] 0 0
Batangas
Country [12] 0 0
Portugal
State/province [12] 0 0
Coimbra
Country [13] 0 0
Portugal
State/province [13] 0 0
Porto
Country [14] 0 0
Slovakia
State/province [14] 0 0
Piestany
Country [15] 0 0
Spain
State/province [15] 0 0
Catalunya
Country [16] 0 0
Thailand
State/province [16] 0 0
Bangkok
Country [17] 0 0
Vietnam
State/province [17] 0 0
VNM

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05232864